Senior Biostatistician

vueverse.; India; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

vueverse. in India is seeking an experienced biostatistician to contribute to protocol design, SAP development and data analysis plans. You will collaborate with clinical, regulatory, medical writing, and data management teams to ensure high-quality study deliverables.

Responsibilities include creating analysis datasets per CDISC ADaM, overseeing randomization, reviewing CRFs, and supporting DSMB/DMC activities. Leadership and mentoring of junior staff are also expected.

Qualifications

• PhD in statistics or biostatistics with 4+ years in CRO/pharma, or Master’s with 7+ years in CRO/pharma.
• Thorough knowledge of CDISC standards, ADaM, and TFL programming.
• Strong proficiency in statistical software (SAS, R).
• Deep understanding of clinical trial methodology and regulatory requirements (FDA/EMA).
• Excellent problem-solving, leadership, communication and collaborative skills.

Responsibilities

• Provide statistical input for protocol development, study design, and sample size calculations.
• Develop Statistical Analysis Plan including data derivation, tables, figures and listings.
• Collaborate with cross-functional teams: clinical, regulatory, medical writing and data management.
• Oversee production and quality control of randomization schedules.
• Review CRFs and data validation guidelines to ensure data quality.
• Design analysis file specifications per the SAP and CDISC ADaM standards.
• Provide statistical input for DSMB/DMC activities and analyses.
• Monitor progress against milestones and escalate out-of-scope tasks to management.
• Ensure compliance with regulatory guidelines and industry standards.
• Prepare and review clinical trial reports and regulatory submissions.
• Mentor junior statisticians and statistical programmers.
• Stay updated with advancements in biostatistics and regulations.

Education

PhD in statistics/biostatistics

Master’s in Biostatistics or Statistics

Tools

SAS

R

CDISC ADaM

TFL programming

Job description

Responsibilities

• Provide statistical input for protocol development, study design, and sample size calculation
• Develop Statistical analysis Plan including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports.
• Collaborate with cross-functional teams including clinical, regulatory, medical writing, and data management
• Oversee production and quality control of randomization schedules
• Review case report forms and data validation guidelines to ensure quality and integrity of study data collection
• Design analysis file specifications in accordance with the statistical analysis plan and table shells, and CDISC ADaM standards
• Provide statistical input for Data Safety Monitoring Board (DSMB)/Data Monitoring Committee (DMC) activities, including development of DSMB/DMC charters and analysis plans, and serve as an independent statistician providing data and analysis support for DSMB/DMC review
• Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalates to management.
• Ensure compliance with regulatory guidelines and industry standards
• Prepare and review clinical trial reports, and regulatory submissions.
• Mentor and provide guidance to junior statistician or biostatistician and statistical programmer
• Stay updated with advancements in biostatistics and relevant regulatory guidelines

Qualifications

• PhD in statistics or biostatistics and 4+ years of experience as a biostatistician in CRO or Pharmaceutical companies or Master’s degree in Biostatistics or statistics, or related field and 7+ years of experience as a biostatistician in CRO or Pharmaceutical companies.
• Thorough knowledge of and experience with CDISC standards, ADaM, and TFL programming.
• Strong proficiency in statistical software (e.g., SAS, R)
• In-depth knowledge in clinical trial methodology, and regulatory requirement(e.g., FDA, EMA)
• Excellent problem-solving skills and attention to detail.
• Strong Leadership, communication and interpersonal skills.
• Ability to effectively manage multiple tasks and projects
• Ability to clearly describe statistical techniques and interpret results